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Completed

NCT Number: NCT06007040

Interstitial Lung Disease Associated

This single-center, retrospective cohort study was conducted to determine whether ANCA-ILD spectrum share the same clinical manifestations and outcome with CTD feature disease spectrum.

Completed

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Key information

Age range

18 year–85 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Peking Union Medical College Hospital

Beijing, Beijing Municipality, 100730, China

About this study

We retrospectively reviewed patients who had been diagnosed with interstitial pneumonia during outpatient or hospitalization at Peking Union Medical College Hospital (PUMCH) between January 2012 and December 2021.

  • Baseline data collection:
  • Baseline information at the time of initial diagnosis was obtained, and the following items were analyzed: demographic information (age, gender), clinical course, clinical symptoms and signs, laboratory findings [routine blood, erythrocyte sedimentation rate (ESR), hypersensitivity C-reactive protein (Hs-CRP), rheumatoid factor (RF) and serologic autoantibodies], pulmonary function tests (PFTs), and chest HRCT scans.
  • MPO-ANCA and PR3-ANCA titers were measured by ELISA.
  • Chest HRCT images were evaluated by at least two pulmonologists and radiologists. The HRCT scans were analyzed for the following characteristics: ground-glass opacities, reticular patterns, honeycombing, traction bronchiectasis.
  • Spirometry was performed according to standardized guidelines. PFTs results were expressed as percentages of the predicted values, thereby correcting for age, gender and bodyweight.
  • Treatment was defined as the use of corticosteroids ≥ 10mg/d, azathioprine, cyclophosphamide, mycophenolate mofetil, methotrexate, or rituximab. Follow-up was up to the time of patient's last visit or time of death, and the outcomes were defined as death from all causes.
  • Outcome

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Males and females
  • Aged from 18 to 85 years with informed consent
  • Have a diagnosis of ILD based on clinical symptoms and radiologic features, with or without histopathologic results

Exclusion criteria

  • ILD induced by drug, environment, or occupational exposure
  • Hypersensitivity pneumonitis and sarcoidosis

Treatment and study plan

Primary outcomes

  1. All-cause mortality

    Time frame: From baseline until the date of death from all cause, up to 5 years

    death from all causes

Sponsors and collaborators

Lead sponsor

Peking Union Medical College Hospital

Other

Registry information

Important dates

Study start
2012
Primary completion
2021
Study completion
2021
First posted
Aug 23, 2023
Registry last updated
Aug 23, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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